Inside Health Policy | FDA Inspection Plans Unclear as EUAs Move toward Full Approvals

This week, Congress passed a bill raising the nation’s debt limit to avoid a potential default and CMS issued a final rule rescinding COVID-19 vaccine requirements for facilities participating in Medicare and Medicaid. 

Cathy Burgess comments on how the U.S. Food and Drug Administration is likely to use remote evaluations to resolve as many issues as possible before returning to onsite inspections of facilities.

Cathy Burgess is quoted on COVID-19 safety considerations for Food and Drug Administration inspections.

This week, the COVID-19 PHE expired, and DEA issued a final rule that provides a six-month extension of PHE flexibilities that allow the prescription of controlled substances via telemedicine.